Research Study Fact Sheet For Referring Physicians Sudden Sensorineural Hearing Loss Multicenter Treatment Trial

What is the purpose of the study?

This study is a prospective Randomized Controlled Trial comparing efficacy and risk of oral prednisone to intratympanic (IT) methylprednisolone in primary treatment of idiopathic sudden sensorineural hearing loss (SSNHL).

This study is funded by the NIH National Institute for Deafness and Other Communication Disorders (NIDCD)

This is a national multicenter study with clinical sites at Massachusetts Eye & Ear Infirmary (Boston, MA), University of Massachusetts (Worcester, MA), NYU (New York City, NY), Johns Hopkins University (Baltimore, MD), Cleveland Clinic (Cleveland, OH), University of Michigan (Ann Arbor, MI), University of Iowa (Iowa City, IA), and University of California at San Diego (San Diego, CA)

Who is eligible to participate?

Patients must meet the following criteria to be considered for participation:

Unilateral idiopathic SSNHL of <2 weeks duration

=50 dB PTA in the affected ear

=10 days steroid treatment prior to enrollment

“Out of Plan” referrals are eligible at no cost to participants

What happens to participants?

Participants will undergo a screening evaluation by our Research Coordinator and Clinic Physician, and they will have an audiogram to determine if they are eligible to participate.

If eligible and they choose to participate, they will be randomly assigned to the oral or IT treatment group and receive approximately two weeks of therapy.

They will have a series of four treatment and two follow-up visits over the next six months. At each visit they will be interviewed and examined, have an audiogram, and have blood and urine tests for safety monitoring.

Who do I contact if I have more questions?

The following people are available to answer your questions or concerns:

Mary L. Bartley, RN (Study Coordinator)

Steven D. Rauch, MD (Principal Investigator)

page updated: 1/20/05